Klinisk studie av medicintekniska produkterna PROXERA PSOMED 20 och PROXERA PSOMED 40 för behandling av plackpsoriasis och icke-pustulös palmoplantar psoriasis (PASI)
26 juli 2026 uppdaterad av: ICIM International S.r.l.
Utvärdering av effektiviteten och säkerheten hos medicintekniska produkten PROXERA PSOMED 20 för att minska psoriatiska plack och hos medicintekniska produkten PROXERA PSOMED 40 för att minska icke-pustulös palmoplantar psoriasfläck hos patienter med plackpsoriasis: en sponsrad, interventionell, encenter, randomiserad, enkelblindad, intra-patientkontrollerad studie (PASI)
Denna interventionsstudie med ett centrum var utformad för att utvärdera effektiviteten och säkerheten hos två CE-märkta medicintekniska produkter: PROXERA PSOMED 20 studeras hos deltagare med icke-palmoplantar plackpsoriasis, medan PROXERA PSOMED 40 studeras hos deltagare med icke-pustulös palmoplantar psoriasis.
Studien syftar till att fastställa om behandling av ett målområde med den tilldelade medicintekniska produkten leder till större klinisk förbättring jämfört med den obehandlade kontralaterala kontrollområdet hos samma deltagare. För PROXERA PSOMED 20 utförs den primära bedömningen efter 4 veckors behandling. För PROXERA PSOMED 40 utförs den primära bedömningen efter 8 veckors behandling.
Sekundära mål inkluderar bedömning av säkerhet, lokal tolerabilitet, psoriasisens övergripande utveckling, dess inverkan på livskvalitet och ytterligare parametrar för lokal sjukdomsaktivitet vid målområdena. Deltagarna kommer att applicera den tilldelade studieprodukten en gång dagligen på det valda målområdet, genomgå kliniska bedömningar vid schemalagda besök och lämna information om säkerhet och tolerabilitet under hela studien.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
35
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Paolo Amerio, Professore Ordinario
- Telefonnummer: + 39 0871358032
- E-post: paolo.amerio@unich.it
Studieorter
-
-
Italia
-
Chieti, Italia, Italien, 66100
- Rekrytering
- Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio
-
Kontakt:
- Paolo Amerio, Prof.
- Telefonnummer: + 39 0871358032
- E-post: paolo.amerio@unich.it
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
PROXERA PSOMED 20 - normaliserande kräm, 20% urea
- Diagnos av plackpsoriasis (inte palmoplantar) i minst 1 år PROXERA PSOMED 40 - intensiv exfolierande gel, 40% urea
- Diagnos av icke-pustulär palmoplantar psoriasis i minst 1 år
Gemensamma inklusionskriterier:
- Ålder 18-65 år
- "Lätt" psoriasis svårighetsgrad enligt:
- Psoriasis Area Severity Index (PASI) <10
- Dermatologic Life Quality Index (DLQI) <10
- Body Surface Area (BSA) <10
Exklusionskriterier:
- Produktintolerans
- Samtidig behandling med systemiska immunmodulerande läkemedel (t.ex. metotrexat, cyklosporin, apremilast)
- Samtidig behandling med biologiska läkemedel såsom anti-TNFα, anti-IL17, eller anti-IL23.
- Samtidig lokalbehandling med topikala kortikosteroider (TCS), topikala kalkineurinhämmare (TCI), vitamin D-analoger och kombinationer.
- Gravida eller ammande kvinnor
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intrapatientbehandling med PROXERA PSOMED 20
Enarmad, randomiserad, enkelblind, intraindividuellt kontrollerad studiearm.
Deltagarna tilldelas behandling enligt diagnos: deltagare med icke-palmoplantär plackpsoriasis får PROXERA PSOMED 20 en gång dagligen i 4 veckor på en måltavla, medan deltagare med icke-pustulös palmoplantar psoriasis får PROXERA PSOMED 40 en gång dagligen i 8 veckor på ett målfält på handflatan eller fotsulan.
I båda kohorterna förblir ett jämförbart kontralateralt målfält obehandlat som kontroll.
För PROXERA PSOMED 40 avbryts behandlingen i 3 dagar var 14:e dag.
|
Proxera Psomed 20: Topikalt medicinskt hjälpmedel i krämformulering som innehåller 20 % urea, levereras i en tub på 200 ml. Det appliceras av deltagaren själv en gång dagligen vid samma tidpunkt på dagen på den valda målfokusen under 4 veckor, enligt fingertipsenhetsregeln. Den kontralaterala jämförbara målfokusen förblir obehandlad som kontroll. Proxera Psomed 40: Topikalt medicinskt hjälpmedel i gelformulering som innehåller 40 % urea, levereras i en tub på 100 ml. Det appliceras av deltagaren själv en gång dagligen vid samma tidpunkt på dagen på det valda målfokuset på handflatan eller fotsulan under 8 veckor, enligt fingertipsenhetsregeln. Behandlingen avbryts i 3 dagar var 14:e dag. Den kontralaterala jämförbara målfokusen förblir obehandlad som kontroll.
Andra namn:
|
|
Experimentell: Intrapatientbehandling med PROXERA PSOMED 40
Deltagare med icke-pustulös palmoplantar psoriasis applicerar själva PROXERA PSOMED 40 en gång dagligen vid samma tidpunkt på en målhandflata eller fotsula i 8 veckor.
Dosen appliceras enligt fingertoppsenhetsregeln.
En jämförbar kontralateral målarea förblir obehandlad som kontroll.
Behandlingen avbryts i 3 dagar var 14:e dag.
|
Proxera Psomed 20: Topikalt medicinskt hjälpmedel i krämformulering som innehåller 20 % urea, levereras i en tub på 200 ml. Det appliceras av deltagaren själv en gång dagligen vid samma tidpunkt på dagen på den valda målfokusen under 4 veckor, enligt fingertipsenhetsregeln. Den kontralaterala jämförbara målfokusen förblir obehandlad som kontroll. Proxera Psomed 40: Topikalt medicinskt hjälpmedel i gelformulering som innehåller 40 % urea, levereras i en tub på 100 ml. Det appliceras av deltagaren själv en gång dagligen vid samma tidpunkt på dagen på det valda målfokuset på handflatan eller fotsulan under 8 veckor, enligt fingertipsenhetsregeln. Behandlingen avbryts i 3 dagar var 14:e dag. Den kontralaterala jämförbara målfokusen förblir obehandlad som kontroll.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 4
Tidsram: Baseline to Week 4 (end of treatment)
|
The Target Lesion Score assesses the severity of a representative psoriatic plaque based on erythema, induration (thickness), and scaling.
Each component is scored from 0 to 4, and the total score ranges from 0 to 12, with higher scores indicating greater lesion severity.
In participants treated with PROXERA PSOMED 20, the outcome compares the change from baseline to Week 4 in the treated target plaque with the change in the contralateral untreated control plaque.
|
Baseline to Week 4 (end of treatment)
|
|
Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 8
Tidsram: Baseline to Week 8 (end of treatment)
|
The local modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) assesses erythema, induration, scaling, and extent of involvement in each target palm or sole area.
Erythema, induration, and scaling are each scored from 0 to 4, while extent of involvement is scored from 0 to 6.
For each target site, the local score is calculated as (erythema + induration + scaling) × extent and ranges from 0 to 72, with higher scores indicating more severe disease.
In participants treated with PROXERA PSOMED 40, the primary analysis compares the change from baseline to Week 8 in the treated target area with the change in the contralateral untreated control area.
|
Baseline to Week 8 (end of treatment)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 8
Tidsram: Baseline to Week 8 (4 weeks after the end of treatment)
|
The Target Lesion Score assesses the severity of a representative psoriatic plaque based on erythema, induration (thickness), and scaling.
Each component is scored from 0 to 4, and the total score ranges from 0 to 12, with higher scores indicating greater lesion severity.
In participants treated with PROXERA PSOMED 20, the outcome compares the change from baseline to Week 8 in the treated target plaque with the change in the contralateral untreated control plaque.
|
Baseline to Week 8 (4 weeks after the end of treatment)
|
|
Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 12
Tidsram: Baseline to Week 12 (4 weeks after the end of treatment)
|
The local modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) assesses erythema, induration, scaling, and extent of involvement in each target palm or sole area.
Erythema, induration, and scaling are each scored from 0 to 4, while extent of involvement is scored from 0 to 6.
For each target site, the local score is calculated as (erythema + induration + scaling) × extent and ranges from 0 to 72, with higher scores indicating more severe disease.
In participants treated with PROXERA PSOMED 40, the outcome compares the change from baseline to Week 12 in the treated target area with the change in the contralateral untreated control area.
|
Baseline to Week 12 (4 weeks after the end of treatment)
|
|
Change From Baseline in Psoriasis Area and Severity Index Score at Week 4 in the PROXERA PSOMED 20 Cohort
Tidsram: Baseline to Week 4 (end of treatment)
|
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions.
The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity.
This outcome measures the change in PASI score from baseline to Week 4 in participants with non-palmoplantar plaque psoriasis treated with PROXERA PSOMED 20.
The assessment is used to determine whether changes observed in the target plaque occur independently of, or in parallel with, changes in overall psoriasis severity.
|
Baseline to Week 4 (end of treatment)
|
|
Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 40 Cohort
Tidsram: Baseline to Week 8 (end of treatment)
|
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions.
The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity.
This outcome measures the change in PASI score from baseline to Week 8 in participants with non-pustular palmoplantar psoriasis treated with PROXERA PSOMED 40.
The assessment is used to determine whether changes observed in the target palm or sole area occur independently of, or in parallel with, changes in overall psoriasis severity.
|
Baseline to Week 8 (end of treatment)
|
|
Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 20 Cohort
Tidsram: Baseline to Week 8 (4 weeks after the end of treatment)
|
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions.
The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity.
This outcome measures the change in PASI score from baseline to Week 8 in participants with non-palmoplantar plaque psoriasis treated with PROXERA PSOMED 20.
The assessment evaluates overall psoriasis severity 4 weeks after the end of treatment.
|
Baseline to Week 8 (4 weeks after the end of treatment)
|
|
Change From Baseline in Psoriasis Area and Severity Index Score at Week 12 in the PROXERA PSOMED 40 Cohort
Tidsram: Baseline to Week 12 (4 weeks after the end of treatment)
|
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions.
The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity.
This outcome measures the change in PASI score from baseline to Week 12 in participants with non-pustular palmoplantar psoriasis treated with PROXERA PSOMED 40.
The assessment evaluates overall psoriasis severity 4 weeks after the end of treatment.
|
Baseline to Week 12 (4 weeks after the end of treatment)
|
|
Change From Baseline in Dermatology Life Quality Index Score at Week 4 in the PROXERA PSOMED 20 Cohort
Tidsram: Baseline to Week 4 (end of treatment)
|
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment.
Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life.
This outcome measures the change in DLQI score from baseline to Week 4 in participants treated with PROXERA PSOMED 20.
|
Baseline to Week 4 (end of treatment)
|
|
Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 40 Cohort
Tidsram: Baseline to Week 8 (end of treatment)
|
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment.
Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life.
This outcome measures the change in DLQI score from baseline to Week 8 in participants treated with PROXERA PSOMED 40.
|
Baseline to Week 8 (end of treatment)
|
|
Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 20 Cohort
Tidsram: Baseline to Week 8 (4 weeks after the end of treatment)
|
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment.
Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life.
This outcome measures the change in DLQI score from baseline to Week 8 in participants treated with PROXERA PSOMED 20, 4 weeks after the end of treatment.
|
Baseline to Week 8 (4 weeks after the end of treatment)
|
|
Change From Baseline in Dermatology Life Quality Index Score at Week 12 in the PROXERA PSOMED 40 Cohort
Tidsram: Baseline to Week 12 (4 weeks after the end of treatment)
|
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment.
Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life.
This outcome measures the change in DLQI score from baseline to Week 12 in participants treated with PROXERA PSOMED 40, 4 weeks after the end of treatment.
|
Baseline to Week 12 (4 weeks after the end of treatment)
|
|
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 4
Tidsram: Baseline to Week 4 (end of treatment)
|
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function.
Higher TEWL values indicate greater water loss and greater impairment of the skin barrier.
This outcome compares the change from baseline to Week 4 in the PROXERA PSOMED 20-treated target plaque with the change in the contralateral untreated control plaque.
|
Baseline to Week 4 (end of treatment)
|
|
Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 8
Tidsram: Baseline to Week 8 (end of treatment)
|
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function.
Higher TEWL values indicate greater water loss and greater impairment of the skin barrier.
This outcome compares the change from baseline to Week 8 in the PROXERA PSOMED 40-treated target palm or sole area with the change in the contralateral untreated control area.
|
Baseline to Week 8 (end of treatment)
|
|
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 8
Tidsram: Baseline to Week 8 (4 weeks after the end of treatment)
|
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function.
Higher TEWL values indicate greater water loss and greater impairment of the skin barrier.
This outcome compares the change from baseline to Week 8 in the PROXERA PSOMED 20-treated target plaque with the change in the contralateral untreated control plaque, 4 weeks after the end of treatment.
|
Baseline to Week 8 (4 weeks after the end of treatment)
|
|
Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 12
Tidsram: Baseline to Week 12 (4 weeks after the end of treatment)
|
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function.
Higher TEWL values indicate greater water loss and greater impairment of the skin barrier.
This outcome compares the change from baseline to Week 12 in the PROXERA PSOMED 40-treated target palm or sole area with the change in the contralateral untreated control area, 4 weeks after the end of treatment.
|
Baseline to Week 12 (4 weeks after the end of treatment)
|
|
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 4
Tidsram: Baseline to Week 4 (end of treatment)
|
Vascular density is assessed non-invasively by dermato-capillaroscopy and is recorded separately for the treated target plaque and the contralateral untreated control plaque.
This outcome compares the change in vascular density from baseline to Week 4 between the two target plaques in participants treated with PROXERA PSOMED 20.
|
Baseline to Week 4 (end of treatment)
|
|
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 8
Tidsram: Baseline to Week 8 (4 weeks after the end of treatment)
|
Vascular density is assessed non-invasively by dermato-capillaroscopy and is recorded separately for the treated target plaque and the contralateral untreated control plaque.
This outcome compares the change in vascular density from baseline to Week 8 between the two target plaques in participants treated with PROXERA PSOMED 20, 4 weeks after the end of treatment.
|
Baseline to Week 8 (4 weeks after the end of treatment)
|
|
Number of Participants With One or More Adverse Events in the PROXERA PSOMED 20 Cohort
Tidsram: From first application through Week 8
|
All solicited and unsolicited adverse events, adverse device effects, and serious adverse events occurring during treatment or follow-up will be recorded and assessed by the investigator.
Particular attention will be given to local reactions such as burning, erythema, itching, skin rash, irritation, and allergic contact dermatitis.
The outcome is the number and proportion of participants experiencing at least one adverse event.
|
From first application through Week 8
|
|
Number of Participants With One or More Adverse Events in the PROXERA PSOMED 40 Cohort
Tidsram: From first application through Week 12
|
All solicited and unsolicited adverse events, adverse device effects, and serious adverse events occurring during treatment or follow-up will be recorded and assessed by the investigator.
Particular attention will be given to local reactions such as burning, erythema, itching, skin rash, irritation, and allergic contact dermatitis.
The outcome is the number and proportion of participants experiencing at least one adverse event.
|
From first application through Week 12
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 april 2026
Primärt slutförande (Beräknad)
25 november 2026
Avslutad studie (Beräknad)
23 december 2026
Studieregistreringsdatum
Först inskickad
16 april 2026
Först inskickad som uppfyllde QC-kriterierna
16 april 2026
Första postat (Faktisk)
22 april 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
- Psoriasis Area Severity Index
- Plack Psoriasis
- Urea
- Randomiserad studie
- Enkelblind studie
- Topiskt medicintekniskt produkter
- Intrapatientkontrollerad studie
- Icke-pustulös palmoplantar psoriasis
- PROXERA PSOMED 20
- PROXERA PSOMED 40
- Målläsionspoäng
- Dermatologiskt Livskvalitetsindex
- modifierad Palmoplantar Psoriasis Area Severity Index
- Trans Epidermal Vattenförlust
- dermato-kapillaroskopi
Andra studie-ID-nummer
- Id 286
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individuella deltagardata kommer inte att göras offentligt tillgängliga.
Studiedata är konfidentiella och ägs av Studienarrangören.
Deltagardata hanteras i enlighet med tillämpliga dataskyddslagar och är kodade för att skydda konfidialiteten.
Alla publikationer av studieresultat är föremål för Studienarrangörens och Huvudundersökarens granskning och godkännande i enlighet med studiens publiceringspolicy.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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